Alessandro Buoncompagni

University of Bologna, Italy

Between Innovation and Prohibition: The European Legal and Ethical Framework on Human Germline Genome Editing and the Role of Criminal Law as a Safeguard.

The contribution examines the European legal and ethical framework governing human germline genome editing (HGGE), with particular attention to the role of criminal law as a safeguard against practices considered incompatible with fundamental values. The rapid development of genome editing technologies, especially following the advent of CRISPR-Cas systems, has transformed what was once a speculative ethical debate into a concrete regulatory challenge. The announcement in 2018 of the birth of genetically edited children marked a turning point, exposing the limits of existing governance mechanisms and highlighting the insufficiency of scientific self-regulation and non-binding ethical guidelines.

From a legal perspective, HGGE presents distinctive features that strain traditional regulatory paradigms. Its heritable nature, irreversibility, and the impossibility of obtaining consent from those most affected - future persons and subsequent generations - differentiate it sharply from other biomedical interventions. These characteristics render ex post remedies largely ineffective and complicate reliance on individual autonomy or liability-based models. While ethical and biomedical debates often focus on safety, therapy versus enhancement, and research integrity, this doctrinal analysis argues that such considerations alone cannot fully explain the persistent and categorical resort to criminal prohibitions across Europe.

The analysis proceeds by outlining the ethically and legally salient features of HGGE. The present study examines the International and European legal framework, with particular emphasis on the Oviedo Convention and the indirect but significant role of EU law through sectoral regulation and forms of “functional prohibition.” It then offers a comparative analysis of selected national legal systems—Germany, France, Italy, and the United Kingdom—revealing a convergence despite divergent constitutional traditions and regulatory models. Across these jurisdictions, reproductive applications of germline genome editing are consistently prohibited and supported by criminal sanctions, even where research uses may be conditionally permitted.

A key analytical contribution of the work lies in its clarification of the normative distinction between embryo research and reproductive germline modification. While non-reproductive embryo research conducted under strict oversight may raise serious ethical concerns, it does not engage the same transgenerational implications as reproductive applications resulting in heritable genetic modification. On this basis, the argument put forward is that criminal liability can be normatively justified only once genome editing crosses into clinical trials or reproductive use aimed at implantation, whereas extending criminal sanctions to preclinical or non-reproductive research would risk undermining the principle of extrema ratio and chilling legitimate scientific inquiry.

The central contribution of the article lies in its reconstruction of the protected legal good underlying the observed convergence. It argues that criminal law in the field of HGGE is best understood as safeguarding a trans-individual and transgenerational conception of human dignity. On this account, criminal prohibitions are not primarily aimed at preventing demonstrable harm to identifiable individuals, but at averting irreversible forms of instrumentalisation of humanity associated with the deliberate redesign of human reproduction. Heritability thus emerges as the decisive legal threshold triggering criminal intervention.

Finally, the work reflects on the European dimension, arguing that while limited EU involvement in criminal law may be justified to address enforcement gaps in an integrated legal space, any such intervention must remain cautious, subsidiarity-sensitive, and firmly anchored in the protection of fundamental values rather than broad harmonisation.